Revascularization

iFR and FFR are equally safe to diagnose and treat heart disease according to largest-ever analysis of new real-world, long-term data

Retrieved on: 
Thursday, October 26, 2023
Clinical Science (journal), Gold standard, European Society of Cardiology, AEX, Public sector banks in India, American College, Interventions, NYSE, INT, PHG, Pilot in command, ESC, Pressure, Lund University, Safety, Revascularization, American Heart Association, JACC, Risk, Guideline, MACE, PCI, Blood, FFR, TCT, Patient, Diagnosis, Death, EACTS, American College of Cardiology, Medical device, Pharmaceutical industry, Medical imaging, Cardiology

iFR is an innovative pressure-derived index only offered by Philips that is used to assess coronary blockages during interventional procedures.

Key Points: 
  • iFR is an innovative pressure-derived index only offered by Philips that is used to assess coronary blockages during interventional procedures.
  • The analysis, “Long-term Safety of Revascularization Deferral Based on Instantaneous Wave-Free Ratio or Fractional Reserve,” compares patient outcomes using iFR and FFR in the diagnosis and treatment of heart disease.
  • The cumulative MACE risks for each group differentiated by 1.6% (iFR: 21.5%, FFR: 19.9%, HR 1.09 (95% CI: 0.90-1.33 at 5 years).
  • iFR is considered the Gold Standard for hyperemia-free physiologic assessment for measuring pressure in diagnostic and interventional procedures [1,4].

Concept Medical received IDE approval to investigate safety and efficacy of its MagicTouch Sirolimus Coated Balloon Catheter for the treatment of small coronary artery disease

Retrieved on: 
Monday, May 1, 2023
Stent, Small Vessel, Investigational device exemption, Cardiac muscle, PTA, Restenosis, CAD, ISR, Revascularization, MACE, Trial of the century, PCI, Microangiopathy, Sirolimus, PMA, Patient, Physician, Risk, IDE, Coronary artery disease, FDA, SCB, Cutaneous small-vessel vasculitis, Drug-eluting stent, US FDA, Safety, Pharmaceutical industry, MD, TITAN

TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.

Key Points: 
  • TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.
  • US FDA, on the 25th of April 2023, granted the third IDE approval for Concept Medical's Sirolimus Coated Balloon – MagicTouch SCB.
  • Along with this latest IDE approval for the treatment of Small Vessel indication, Concept Medical received two other IDE approvals for the MagicTouch SCB family of products for the treatment of coronary In-Stent Restenosis (ISR) indication and Below-the-Knee indication (PTA).
  • The current IDE approval will allow Concept Medical to initiate pivotal clinical study to support safety and effectiveness of the MagicTouch SCB in small vessel coronary disease.

Concept Medical received IDE approval to investigate safety and efficacy of its MagicTouch Sirolimus Coated Balloon Catheter for the treatment of small coronary artery disease

Retrieved on: 
Monday, May 1, 2023
Stent, Small Vessel, Investigational device exemption, Cardiac muscle, PTA, Restenosis, CAD, ISR, Revascularization, MACE, Trial of the century, PCI, Microangiopathy, Sirolimus, PMA, Patient, Physician, Risk, IDE, Coronary artery disease, FDA, SCB, Cutaneous small-vessel vasculitis, Drug-eluting stent, US FDA, Safety, Pharmaceutical industry, MD, TITAN

TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.

Key Points: 
  • TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.
  • US FDA, on the 25th of April 2023, granted the third IDE approval for Concept Medical's Sirolimus Coated Balloon – MagicTouch SCB.
  • Along with this latest IDE approval for the treatment of Small Vessel indication, Concept Medical received two other IDE approvals for the MagicTouch SCB family of products for the treatment of coronary In-Stent Restenosis (ISR) indication and Below-the-Knee indication (PTA).
  • The current IDE approval will allow Concept Medical to initiate pivotal clinical study to support safety and effectiveness of the MagicTouch SCB in small vessel coronary disease.

Amarin Announces New REDUCE-IT® Data at ACC.23/WCC Showing Benefit of VASCEPA®/VAZKEPA® (Icosapent Ethyl) in High-Risk Patients with a Recent Acute Coronary Syndrome Event

Retrieved on: 
Sunday, March 5, 2023
Acute coronary syndrome, Revascularization, PAD, MI, Risk, Professional corporation, Pharmaceutical industry, Patient

DUBLIN, Ireland and BRIDGEWATER, N.J., March 05, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced a new analysis from the VASCEPA/VAZKEPA (icosapent ethyl) cardiovascular outcomes REDUCE-IT study showing the effectiveness of VASCEPA®/VAZKEPA® in patients with recent acute coronary syndrome (

Key Points: 
  • The data were presented at the American College of Cardiology’s 72nd Annual Scientific Session together with the World Heart Federation’s World Congress of Cardiology in New Orleans, LA.
  • The absolute risk reduction for first events with IPE treatment in patients with ACS ≥12 months was 4.7% with an NNT of 21.
  • Overall tolerability and adverse event patterns with IPE and placebo in patients with recent ACS were consistent with the full study.
  • Bleeding event rates were no more frequent with IPE than placebo despite extensive use of dual antiplatelet therapy.

Philips showcases clinical data and solutions designed to deliver better cardiac care with greater efficiency at TCT 2022

Retrieved on: 
Friday, September 16, 2022
PVD, Safety, Journal, Efficiency, Beth Israel Deaconess Medical Center, Research, PHG, Patient, Physician, Technology, Cardiology, Control, Philips, Aortic valve, Electrophysiology, 2D, Revascularization, Instant, Pilot in command, American College, 3D, Assistant, Sale, Journal of Comparative Effectiveness Research, List of Dove Medical Press academic journals, Interventional cardiology, Treatment, PCI, Decision-making, Guideline, NYSE, MD, Association, EPIQ, Length of stay, Physiology, AEX, SAS, ISR, Moyamoya disease, ESC, Appropriate use criteria, Veni, vidi, vici, Workflow, Health, TAVR, Calendar, Journal of the American College of Cardiology, Solution, General manager, Telemetry, Harvard Medical School, JACC, MCOT, IVUS, TCT, Medical imaging, Medicine, Medical device, Silviculture, Medicine

In addition, the company will present key clinical data, including global consensus data which highlights the importance of IVUS for both arterial and venous procedures.

Key Points: 
  • In addition, the company will present key clinical data, including global consensus data which highlights the importance of IVUS for both arterial and venous procedures.
  • At Philips, we are fully focused on supporting physicians to improve the health and well-being of the patients they serve.
  • Visitors to TCT 2022 will have access to Philips latest solutions, plus opportunities to engage with clinical experts and experience innovative cardiac solutions.
  • Visit the Philips Engagement Hub to experience innovative cardiac solutions and follow the #TCT2022 conversation on @PhilipsLiveFrom throughout the event.

Two-year data from the TOBA II BTK clinical trial demonstrate durability of dissection repair below the knee with the Philips Tack Endovascular System

Retrieved on: 
Thursday, June 3, 2021
Medicine, Clinical medicine, Health sciences, Bruton's tyrosine kinase, Angioplasty, TIMI, Clinical trial, Revascularization, Osteochondritis dissecans

Amsterdam, the Netherlands Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced positive two-year results from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial.

Key Points: 
  • Amsterdam, the Netherlands Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced positive two-year results from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial.
  • Across all patients in the TOBA II BTK clinical trial at two years, 73.6% had freedom from clinically driven target lesion revascularization (CD-TLR) and did not require a repeat procedure for the treated artery segment.
  • These positive two-year data reiterate the clinical importance of below-the-knee dissection repair and validates the sustained durability of Tack-optimized interventions.
  • The two-year TOBA II BTK data also show sustained improvement in patients quality of life.

Rapid Medical Announces Closing of $50m Series D Financing

Retrieved on: 
Tuesday, May 25, 2021
General Health, Health, Medical devices, Revascularization, Vascular surgery, Jefferies Group

Rapid Medical, a company focused on the development of responsive, adjustable neurovascular devices, announced today that it has completed an oversubscribed Series D financing of $50M.

Key Points: 
  • Rapid Medical, a company focused on the development of responsive, adjustable neurovascular devices, announced today that it has completed an oversubscribed Series D financing of $50M.
  • Rapid Medical recently announced the FDA clearance of its TIGERTRIEVER revascularization device for use in the treatment of ischemic stroke.
  • As part of the financing round, Chen Chen, a principle at CPE, will join Rapid Medicals board of directors.
  • Jefferies LLC served as exclusive placement agent for Rapid Medical in the financing.

Silk Road Medical to Present at BofA Securities 2021 Virtual Health Care Conference

TCAR, Vascular diseases, Vascular surgery, Carotid artery stenosis, Stroke, Revascularization, Silkroad, Medicine

b'SUNNYVALE, Calif., May 03, 2021 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the company will be participating in a fireside chat at the upcoming BofA Securities 2021 Virtual Health Care Conference.\nSilk Road Medical\xe2\x80\x99s management is scheduled to present on Wednesday, May 12, 2021 at 11:00 a.m. Eastern Time.

Key Points: 
  • b'SUNNYVALE, Calif., May 03, 2021 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the company will be participating in a fireside chat at the upcoming BofA Securities 2021 Virtual Health Care Conference.\nSilk Road Medical\xe2\x80\x99s management is scheduled to present on Wednesday, May 12, 2021 at 11:00 a.m. Eastern Time.
  • Interested parties may access a live and archived webcast of the presentation on the \xe2\x80\x9cInvestors\xe2\x80\x9d section of the company\xe2\x80\x99s website at: https://investors.silkroadmed.com/ .\nSilk Road Medical, Inc. (NASDAQ: SILK), is a medical device company located in Sunnyvale, California, that is focused on reducing the risk of stroke and its devastating impact.
  • The company has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR).
  • For more information on how Silk Road Medical is delivering brighter patient outcomes through brighter clinical thinking, visit www.silkroadmed.com and connect on Twitter , LinkedIn and Facebook .\n'

Rapid Medical Receives FDA Clearance for the First Adjustable Stent Retriever for Use in Ischemic Stroke Treatment

Retrieved on: 
Thursday, March 25, 2021
Medical devices, Health, FDA, Surgery, Cardiology, Biotechnology, Stroke, Revascularization, Ischemia, Medicine, Health care

Rapid Medical, developer of responsive, adjustable neurovascular devices, announces the FDA clearance of its TIGERTRIEVER revascularization device for use in the treatment of ischemic stroke.

Key Points: 
  • Rapid Medical, developer of responsive, adjustable neurovascular devices, announces the FDA clearance of its TIGERTRIEVER revascularization device for use in the treatment of ischemic stroke.
  • (Photo: Business Wire)
    Ronen Eckhouse, Rapid Medical Co-founder and CEO states, The FDA clearance of TIGERTRIEVER is a significant milestone in the development and growth of Rapids global business.
  • Though currently recognized as the gold standard in treating large vessel ischemic stroke, traditional stent retrievers have significant limitations.
  • Rapid Medical develops the premier responsive interventional devices for neurovascular diseases such as ischemic and hemorrhagic stroke.

Diabetic Foot Ulcer Treatment Market Expected to Witness a High Jump as the Market is Projected to Grow with a CAGR of 17.0% During the Study Period (2018-2030) | DelveInsight

Retrieved on: 
Monday, March 1, 2021
Medicine, Clinical medicine, Diabetes, Health, Foot diseases, Diabetic foot ulcer, Diabetic foot, Complications of diabetes, DFU, Ulcer, Revascularization, Wound

The Diabetic Foot Ulcer market report also proffers an analysis of recent Diabetic Foot Ulcer treatment algorithm/practice, market drivers, market barriers, and unmet medical needs.

Key Points: 
  • The Diabetic Foot Ulcer market report also proffers an analysis of recent Diabetic Foot Ulcer treatment algorithm/practice, market drivers, market barriers, and unmet medical needs.
  • Diabetic Foot Ulcer (DFU)is one of the most significant and devastating complications of diabetes mellitus, and probably the major component of the diabetic foot.
  • The gold standard for Diabetic Foot Ulcer treatment includes debridement of the wound, management of any infection, revascularization procedures when indicated, and off-loading of the ulcer.
  • However, the burden of high cost in Diabetic Foot Ulcer treatment, post-operative challenges in Diabetic Foot Ulcer patients, and unavailability of specialists lead to restraints in Diabetic Foot Ulcer market growth.